Instrument Software validation Engineer - W2 Only

Job Title: Instrument Software validation Engineer Location- Remote W2 Position Name CoreLIMS

GAMP

GxP Assessment

Medical Devices regulations

Medical device development

Software validation

CSV

Key Responsibilities Document and validate software installed on lab instruments per EMA regulatory standards.

Validate Instruments and Instrument Integration

Migrate instrument software management to align with PPD IT SOPs.

Capture and document software requirements and configurations.

Develop validation test cases and protocols related to Instruments/Medical devices, integrations and downstream workflow validation

Create infrastructure and data flow diagrams.

Conduct comprehensive risk assessments.

Collaborate with cross-functional teams including IT, QA, and lab operations.

Required Skills & Qualifications Proven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environment.

Strong technical writing skills for documentation and test case development.

Excellent communication skills to interact with cross-functional teams.

Highly detail-oriented with a focus on compliance and accuracy.

Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.

Experience with risk assessment methodologies and validation lifecycle documentation.

What are the top 3 skills required for this role?

• Insturment / Medical devices software validation
• Instrument integration and downstream workflow validation
• Document and validate software installed on lab instruments per EMA regulatory standards

Years Of Experience Required Mid to Senior Level professionals with 6 10+ years of relevant experience.

Prior experience in lab instrumentation software validation is highly desirable.